NCT02567578终止2 期
A Multicenter, Randomized, Double-blind, Placebo-controlled Dose-finding Phase 2 Trial to Evaluate the Efficacy and Safety of YH12852 in Patients With Functional Dyspepsia
Yuhan Corporation1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2015年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Ratio of OTE (Overall Treatment Efficacy) responders
研究概览
简要总结
This is a multicenter, randomized, double-blind, placebo-controlled dose-finding phase 2 trial to evaluate the efficacy and safety of YH12852 in patients with functional dyspepsia.
详细描述
Eligible subjects will be randomized into one of 4 groups; YH12852 0.1 mg, 0.25 mg, 0.5 mg, or placebo at the same ratio and will be administered investigational products orally, twice daily for 4 weeks and followed up for 2 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must be willing and able to provide written informed consent.
- •BMI of < 35 kg/m2
- •Patients experiencing one or more of functional dyspepsia symptoms beginning at least 6 months prior according to Rome III criteria, with the symptom(s) evident over the last 3 months at the time of screening
- •Patients with no evidence of organic lesions based on upper GI endoscopy, which could be the cause of dyspeptic symptoms
- •Women of childbearing potential (WOCBP) must have a negative pregnancy test result at the screening visit and use an adequate method of contraception to avoid pregnancy throughout the study
排除标准
- •Women who are pregnant or breastfeeding.
- •Women with a positive pregnancy test result on enrollment or prior to investigational product administration.
- •Subjects with a history of surgery that could affect gastrointestinal motility
- •Subjects with inflammatory bowel disease
- •Clinically significant chronic infection (eg. AIDS, etc), or significant medical or psychiatric illness.
- •Serious cardiovascular disease (including QT prolongation defined as QTc interval ≥ 450msec) or respiratory disease
- •History of alcohol or drug abuse within the previous one year.
- •Subjects with mental illness (e.g. schizophrenia, dementia etc) that may render the inability to complete the study
- •Physical and Laboratory Test Findings
- •Administration of any other investigational product or participation in other clinical trials within 3 months prior to randomization.
研究组 & 干预措施
YH12852 0.1 mg
Experimental
twice daily for 4 weeks
干预措施: YH12852 0.1 mg (Drug)
YH12852 0.25 mg
Experimental
twice daily for 4 weeks
干预措施: YH12852 0.25 mg (Drug)
YH12852 0.5 mg
Experimental
twice daily for 4 weeks
干预措施: YH12852 0.5 mg (Drug)
Placebo
Placebo Comparator
twice daily for 4 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Ratio of OTE (Overall Treatment Efficacy) responders
时间窗: 4 weeks
次要结局
- Ratio of OSS responders(4 weeks)
- Elimination rate for 8 functional dyspepsia symptoms(4 weeks)
- Change from basline in NDI QoL score(4 weeks)
研究者
研究点 (1)
Loading locations...
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